| 商品名称 | Nilotinib Accord |
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| 适用类别 | Human |
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| 治疗领域 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
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| 通用名/非专利名称 | nilotinib |
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| 活性成分 | nilotinib |
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| 产品号 | EMEA/H/C/006315 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | L01EA03 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2024/08/22 |
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| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
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| 人用药物治疗学分组 | Antineoplastic agents |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2024/06/27 |
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| 修订号 | |
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| 治疗适应症 | Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2024/06/28 |
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| 最后更新日期 | 2024/09/11 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/nilotinib-accord-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/nilotinib-accord |
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